Pitts, a former FDA associate commissioner, was the agency’s senior official in charge of advisory committees. During my time at the Food and Drug Administration, I was the senior official in charge ...

Add Yahoo as a preferred source to see more of our stories on Google. Before becoming FDA commissioner, Dr. Marty Makary pushed for more advisory committee meetings. - Kent Nishimura/Reuters FDA ...

The recent controversies about the safety of antidepressants during pregnancy and hormone therapy for menopause were heightened by how decisions are being made. Earlier this month, HHS officials ...

U.S. Food and Drug Administration (FDA) advisory committees play a key role in evaluating the efficacy and safety of new drugs. They include open public hearing sessions, whereby patients, clinicians, ...

Handpicked panels don't fulfill federal requirements, group argues ...

Before Exelexis’ Cabometyx can pass muster with the FDA in its hopeful neuroendocrine tumors indication next April, it will have to first face the agency’s Oncologic Drugs Advisory Committee (ODAC) in ...

Overall, 82%, 11%, and 7% of speakers supported drug approval, opposed approval, and were neutral, respectively. (HealthDay News) — Most speakers attending US Food and Drug Administration (FDA) Human ...

PRINCETON, N.J.--(BUSINESS WIRE)--UroGen (NASDAQ: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced ...

Lizzy Lawrence leads STAT’s coverage of the Food and Drug Administration. She was previously a medical devices reporter. You can reach Lizzy on Signal at lizzylaw.53. The Food and Drug Administration ...

FDA leaders under President Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency's decisions from public ...